Nutrition Core for Clinical Research Dishes Up Discovery
It’s no secret that the Brigham is a research powerhouse. But what some faculty and staff might be less familiar with is the hospital’s robust, in-house support structure for clinical research — an offering designed to aid Brigham investigators during each stage of their work.
As part of its many support services — including Investigational Drug Services, Clinical Skills Training and Phlebotomy — the Center of Clinical Investigation (CCI) is home to the Brigham’s Nutrition and Metabolic Research Core, which aims to advance nutrition research as an integral component of its overall research studies.
“The Nutrition Core was, is and will remain critical for the success of intensive and long-term, in-laboratory metabolic, sleep and circadian studies like ours,” said Frank Scheer, PhD, associate professor of medicine in the Sleep Medicine Division, who has worked with the team for more than 15 years on trials such as one examining the association between shift work and metabolic disorders. “These studies require the know-how, experience and dedication of a nutrition team to provide calculated meals before and during these in-laboratory protocols that last days, weeks and sometimes months, as well as support for energy expenditure assessments, meal-pattern tracking and nutritional analysis.”
Using a variety of modalities, the Nutrition Core collaborates with investigators like Scheer to provide research diets, nutrition intake data collection and analysis, and patient nutrition assessment services, working closely with the CCI inpatient, outpatient and extended offsite facilities. It also translates nutrition research findings for health professionals and public health policy and application, and makes equipment previously reserved only for research — such as indirect calorimeters that assess resting metabolic rate — available to outpatients through the CCI Nutrition Clinic.
The Secret Sauce
Situated on the 9th floor of the tower is a diet office and state-of-the-art metabolic test kitchen used to precisely prepare controlled-nutrient diets to the gram for research participants, inpatients and outpatients. A satellite kitchen and storeroom are also located at 221 Longwood Ave. Advanced infrastructure and streamlined operations are just a few of the features that help differentiate the Brigham’s Nutrition Core from other research centers.
“We have an extra level of intricacy in our processes to precisely monitor and control food intake among participants,” said Demsina Babazadeh, MPH, RD, LDN, CNSC, director of Nutrition and Metabolic Research, adding that her team provides all services in accordance with research study and design, protocol order and participant requirements.
Other features include tenured staff and specialized expertise: The Nutrition and Metabolic Research team comprises registered dietitian nutritionists, each of whom are licensed in the state of Mass. and hold a master’s degree. Combined, the team, including metabolic technicians, has more than 80 years of nutrient-controlled diet production experience and more than 40 years’ worth of nutrition research, design and implementation experience.
The team also has sophisticated software at its fingertips, such as the nutrition data system for research (NDSR) for diet analysis of food records, food nutrition evaluation software for controlled nutrition diet calculation and glycemic index, and additional software for intake tracking and data export.
The Nutrition and Metabolic Research Core has played a key role in several large-scale feeding trials, such as the Dietary Approaches to Stop Hypertension (DASH) study. According to the American Heart Association, hypertension, or high blood pressure, affects more than 100 million Americans. The DASH trial comprised 459 adults with and without high blood pressure and compared the effects of the DASH eating plan — a heart-healthy diet high in whole grains, fruits and vegetables and low in saturated fat, sodium and sugar — with the typical American diet and the typical American diet with more fruits and vegetables. During the study, the Nutrition Core helped develop menus for a seven-day menu cycle with 21 meals at four calorie levels (1600, 2100, 2600 and 3100 kcal). The team also developed comprehensive weekend menus and meals for trial participants.
After eight weeks, DASH diet participants showed the biggest decrease in blood pressure and LDL cholesterol, both of which are significant risk factors for cardiovascular disease. Most recently, Brigham researchers examined the relationship between DASH and two other diets — the Alternate Mediterranean diet (AMED) and the Alternative Health Eating Index-100 — to determine whether diet may influence the risk of hearing loss.
Brigham investigators also supported the OmniHeart (Optimal Macronutrient Intake Trial for Heart Health) trial by developing and advising on specialized menus. More than 160 adults with systolic blood pressure readings of 120 to 159 millimeters of mercury participated in this trial, which compared three diets — DASH, DASH substituting 10 percent of total daily carbohydrates with protein, and DASH substituting 10 percent of total daily carbohydrates with unsaturated fat. After six weeks, results indicated that either DASH variation reduced blood pressure and improved lipid levels more than the original DASH diet.
“Working on these DASH follow-up studies has been very rewarding from a health-professional standpoint,” said Karen Yee, MS, RDN, LDN, senior research dietitian. “These findings continue to be the basis of our nutritional recommendations, and to help expand upon and evolve that work is one of the main reasons I enjoy working in research; it allows me to play a pivotal role in what my colleagues will recommend to their patients.”